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DDD Update

Daily news and top headlines for drug research professionals

Bausch + Lomb Receives Successful Results from Phase 3 Study

September 26, 2014 10:59 am | News | Comments

Bausch + Lomb announced that its next generation sub-micron gel formulation of loteprednol etabonate was statistically superior to placebo (vehicle gel) in eliminating inflammation and pain following cataract surgery by study day eight, the primary endpoints in the first Phase 3 study. Read more...

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Gilead Gets Positive Opinion for HCV Tablet

September 26, 2014 10:48 am | News | Comments

Gilead Sciences Inc. announced that the CHMP, the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company's Marketing Authorization Application (MAA) for Harvoni, an investigational once-daily tablet combining the NS5A inhibitor (LDV) 90 mg and the nucleotide analog polymerase inhibitor (SOF) 400 mg for the treatment of HCV infection in adults. Read more...

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AstraZeneca's Lung Cancer Drug Gets EU Label Update

September 26, 2014 10:32 am | News | Comments

AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a Type-II variation update to the European label for Iressa (gefitinib). The label update will help doctors identify lung cancer patients who could benefit from treatment but are unable to provide a suitable tumor sample. Read more...    

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Roche Launches Global Program for HIV Viral Load Testing

September 26, 2014 10:08 am | News | Comments

Roche announced the launch of a new Global Access Program for HIV viral load testing. To support the Global Access Program, Roche has committed to expanding access to its COBAS AmpliPrep/COBAS TaqMan HIV-1 Test version 2.0 through a special pricing scheme for qualifying organizations in eligible countries. Read more...

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Novo Nordisk Establishes New Obesity Research Unit

September 26, 2014 9:52 am | News | Comments

Novo Nordisk announced that the company will establish a new obesity research unit in Seattle, Washington, in the US. The new unit is a result of Novo Nordisk's increasing focus on treatment of obesity. Read more...                       

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NIH Announces Network to Accelerate Medicines for RA, Lupus

September 25, 2014 3:23 pm | News | Comments

The National Institutes of Health (NIH) has awarded grants to 11 research groups across the United States to establish the Accelerating Medicines Partnership in Rheumatoid Arthritis and Lupus (AMP RA/Lupus) Network. Read more...             

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Pfizer Completes Acquisition of InnoPharma

September 25, 2014 3:03 pm | News | Comments

Pfizer Inc.announced that it has completed its acquisition of the pharmaceutical development company, InnoPharma Inc., following receipt of United States (U.S.) regulatory approval from all government authorities required by the agreement and other closing conditions. Read more...

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MabVax Neuroblastoma Vaccine Gets Orphan Drug Designation

September 25, 2014 2:51 pm | News | Comments

MabVax Therapeutics Holdings Inc. announced that the FDA has granted orphan drug designation to the company's vaccine intended for the treatment of the childhood cancer neuroblastoma. Read more...               

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Pacira Shares Drop as FDA Warns on Misleading Ads

September 25, 2014 2:13 pm | News | Comments

Pacira Pharmaceuticals Inc. said Thursday that it received a warning letter from regulators about marketing for an injectable drug that numbs post-surgical pain that the letter says is misleading. Read more...           

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Chemists Recruit Anthrax to Deliver Cancer Drugs

September 25, 2014 1:58 pm | News | Comments

Bacillus anthracis bacteria have very efficient machinery for injecting toxic proteins into cells, leading to the potentially deadly infection known as anthrax. A team of MIT researchers has now hijacked that delivery system for a different purpose: administering cancer drugs. Read more...

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Boehringer Ingelheim Announces FDA Approval of COPD Drug

September 25, 2014 1:31 pm | News | Comments

Boehringer Ingelheim Pharmaceuticals, Inc. announced that the FDA approved Spiriva Respimat (tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Read more...

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Genzyme to Collaborate on Gene Therapy for Blindness-Causing Disease

September 25, 2014 10:54 am | News | Comments

Genzyme, a Sanofi company announced the establishment of a research collaboration with the University of Florida and the University of Pennsylvania to develop a gene therapy for the treatment of a rare genetic disease that causes childhood blindness. Read more...

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Drug for Rigid Muscles Moves Ahead in Clinical Trials

September 25, 2014 10:40 am | News | Comments

A new formulation for a University of Minnesota-developed drug targeted at rare disorders is under development, with the potential to help a small number of Americans each year. Read more...

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MedImmune, CRUK Partner to Develop New Cancer Biologics

September 25, 2014 10:22 am | News | Comments

AstraZeneca announced that MedImmune, its global biologics research and development arm, and Cancer Research UK, with its commercial arm, Cancer Research Technology (CRT), have entered into an innovative collaboration to establish a joint laboratory in Cambridge, UK. Read more...

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Novartis Psoriatic Arthritis Drug Hits Endpoints in Two Phase 3 Trials

September 25, 2014 10:06 am | News | Comments

Novartis announced that two pivotal Phase 3 studies (FUTURE 1 and FUTURE 2) of AIN457 (secukinumab) in psoriatic arthritis (PsA) met primary and key secondary endpoints. Read more...

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